Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as V118C (Stage 1)
V118C · 2 trials · 2 indications
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants legally acceptable representative (LAR) are specifically asked about and record on their electronic vaccine report card (eVRC). Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be reported.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported.
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported.
A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be recorded.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported.
A SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported.
A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with a solicited injection-site AE will be reported.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with a solicited systemic AE will be reported.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with Immediate AEs following vaccination will be reported.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. An unsolicited AE is an AE that is not solicited using a vaccine report card (VRC) and that is communicated by a participant. The number of participants that experienced an unsolicited AE will be reported.
An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The number of participants who experience an SAE will be reported.
An MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason. The number of participants who experience an MAAE will be reported.
An ECI includes but is not limited to: 1) An overdose defined as: A participant receiving more than 1 dose of study vaccine in a 24-hour period or more than 2 doses of study vaccine throughout the study. 2) Potential drug-induced liver injury (DILI) events defined as: An elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that is ≥3 times the upper limit of normal (ULN) and an elevated total bilirubin lab value that is ≥2 times ULN and, at the same time, an alkaline phosphatase lab value that is \<2 times ULN, as determined by way of protocol-specified laboratory testing or unscheduled laboratory testing. 3) Potential immune-mediated disease (pIMDs) defined as: A subset of AEs that include either an established autoimmune disease(s) or Inflammatory and/or neurologic disorder(s), which might or might not have an autoimmune etiology. The number of participants who experience an ECI will be reported.
| Arm | Type | Description |
|---|---|---|
| V118C (Stage 1) | EXPERIMENTAL | Participants will receive a single 0.5 mL intramuscular (IM) injection of V118C administered at 12 to 15 months of age. |
| V118C (Stage 2) | EXPERIMENTAL | Participants will receive a single 0.5 mL IM injection of V118C administered at 2,4,6, and 12 months of age. |
| PCV20 (Stage 1) | ACTIVE_COMPARATOR | Participants will receive a single 0.5 mL IM injection of PCV20 administered at 12 to 15 months of age. |
| PCV20 (Stage 2) | ACTIVE_COMPARATOR | Participants will receive a single 0.5 mL IM injection of PCV20 administered at 2,4,6, and 12 months of age. |
| V118C | EXPERIMENTAL | Participants receive intramuscular (IM) injection of V118C in a 2-dose regimen administered on Day 1 and Day 29. |
| V118 | EXPERIMENTAL | Participants receive IM injection of V118 in a 2-dose regimen administered on Day 1 and Day 29. |
| PREVNAR 20™ + Saline | ACTIVE_COMPARATOR | Participants receive one dose of IM injection of PREVNAR 20™ in a 2-dose regimen on Day 1 followed by one dose of saline on Day 29. |
| Name | Type | Description |
|---|---|---|
| V118C (Stage 1) | BIOLOGICAL | IM administration of V118C |
| V118C (Stage 2) | BIOLOGICAL | IM administration of V118C |
| PCV20 (Stage 1) | BIOLOGICAL | IM administration of PCV20 |
| PCV20 (Stage 2) | BIOLOGICAL | IM administration of PCV20 |
| V118C | BIOLOGICAL | Intramuscular Administration |
| V118 | BIOLOGICAL | Intramuscular Administration |
| PREVNAR 20™ | BIOLOGICAL | Intramuscular Administration |
| Saline | BIOLOGICAL | Intramuscular Administration |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: Stage 1: * Is previously vaccinated with 3 routine infant doses of Pneumococcal 20-valent conjugate vaccine (PCV20) * Is 12 through 15 months of age Stage 2: \- Is approximately 2 months of age Both S...
V118C is an investigational monoclonal antibody being developed by Merck & Company, Inc. (MRK) for pneumococcal infection and for use in healthy participants. It is currently in Phase 1 clinical development, with studies evaluating the vaccine formulation in both adults and children.
V118C is being studied for use in pneumococcal infection, a bacterial disease that can cause pneumonia, meningitis, and bloodstream infections. It is also being evaluated in healthy participants to assess safety and immune response. The vaccine is intended for prevention, with trials including children as young as 2 months.
V118C is developed by Merck & Company, Inc., a global pharmaceutical company traded on the New York Stock Exchange under the ticker MRK. Merck is conducting clinical trials to evaluate the vaccine's safety and efficacy in preventing pneumococcal disease.
V118C is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. Two Phase 1 trials are listed: one completed study in healthy adults and one actively recruiting study in children.
V118C is being evaluated in two clinical trials. NCT06611033 is a completed Phase 1 study in healthy adults in the United States. NCT07300267 is an actively recruiting Phase 1 study in children with pneumococcal infection, also in the United States, with an enrollment target of 210 participants.
Yes, V118C is also known as V118C (Stage 1). This name distinguishes the specific formulation being tested in early-stage clinical trials. The vaccine is being developed by Merck & Company, Inc. under the ticker MRK.